Product Use and Adaptation, Safety and Tolerability of P3P in Adult Healthy Smokers Switching to it

NCT03953183 | Completed Results

• 1 other identifier: P3P-SE-02-RU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the product use and adaptation in adult, current cigarette smoking subjects between baseline and after one month of use of one of two P3P variants. The effect of P3P use behavior on nicotine pharmacokinetic (PK) profile, acceptability, as well as the safety and tolerability of P3P over a period of 1 month will be investigated.

Conditions

Pharmacokinetics

Keywords

Nicotine

Outcome Measures

Primary Outcomes (4)

• Plasma Nicotine Concentration-time Profile

  To measure the plasma nicotine concentration-time profile following correction of baseline nicotine levels.

  Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.

• Maximum Nicotine Concentration [cCmax]

  To measure the maximum plasma nicotine concentration \[cCmax\] following correction of baseline nicotine levels.

  Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.

• Time to the Maximum Nicotine Concentration [cTmax]

  To measure the time to maximum nicotine concentration \[cTmax\] following correction of baseline nicotine levels.

  Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.

• Area Under the Concentration-time Curve From Start of Product Use (T0) to 4 Hours [cAUC(0-4h)]

  To measure the area under the plasma concentration-time curve \[cAUC(0-4h)\] following correction of baseline nicotine levels.

  Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.

Secondary Outcomes (12)

• Craving for a Cigarette

  Before, during and up to 4 hours post-product use on day 1 and day 30

• Sensory Parameters

  Within 60 minutes after product use on day 1 and day 30.

• Product Experience

  Within 60 minutes after product use on day 1 and day 30.

• Product Dependence

  Within 60 minutes after product use on day 1 and day 30.

• Product Acceptance

  Within 60 minutes after product use on day 1 and day 30.

Study Arms (2)

P3P-1mg

OTHER

Subjects randomized to exclusive use of P3P-1mg

Other: P3P-1mg

P3P-2mg

OTHER

Subjects randomized to exclusive use of P3P-2mg

Other: P3P-2mg

Interventions

P3P-1mg OTHER

P3P-1mg (P3P product containing 1mg of nicotine.)

P3P-1mg

P3P-2mg OTHER

P3P-2mg (P3P product containing 2mg of nicotine.)

P3P-2mg

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed and dated the ICF and is able to understand the information provided in it.
• Subject has been a smoker for at least the last 3 years prior to the Screening Visit and has smoked 5 to 15 commercially available cigarettes per day for the last 3 months prior to Screening.
• Subject has a positive urinary cotinine test (cotinine ≥ 200 ng/mL).
• Subject does not plan to quit smoking within 2 months.
• Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.
• Ready to switch from smoking cigarettes to using P3P for the duration of the study.

You may not qualify if:

• As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical (e.g., psychological and/or social reason).
• Subject has a clinically relevant disease which requires medication or any other clinically significant medical condition, which as per the judgment of the Investigator would jeopardize the safety of the subject.
• Subject has asthma condition (post-bronchodilator FEV1/FVC \< 0.75 and reversibility in FEV1 ≥ 12% and \> 200 mL from pre- to post-bronchodilator values).
• Subject has (FEV1/FVC) \< 0.7 and FEV1 \< 80% predicted value at post-bronchodilator spirometry.
• Subject has a BMI \< 18.5 kg/m2 or \> 32.0 kg/m2.
• Subject has received medication within 14 days or within 5 half-lives of the drug prior to Admission (whichever is longer) which has an impact on CYP2A6 activity.
• Subject has a positive serology test for HIV 1/2, Hepatitis B, or Hepatitis C.
• Subject has a positive alcohol breath test and/or a history of alcohol disorder within the past 2 years.
• Subject has a positive urine drug test.
• Subject has participated in another clinical study within 3 months prior to the Screening Visit.
• Subject has been previously screened or enrolled in this study.
• For women only: subject is pregnant or is breastfeeding.
• For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

LLC Scientific Research Center Eco-Safety

Saint Petersburg, 196143, Russia

Location

Related Publications (1)

• Chrea C, Acquadro C, Afolalu EF, Spies E, Salzberger T, Abetz-Webb L, Cano S, Arnould B, Mainy N, Rose J, Weitkunat R. Developing fit-for-purpose self-report instruments for assessing consumer responses to tobacco and nicotine products: the ABOUT Toolbox initiative. F1000Res. 2018 Dec 2;7:1878. doi: 10.12688/f1000research.16810.1. eCollection 2018.

  PMID: 30906527 BACKGROUND

Results Point of Contact

• Title: Christelle Haziza
• Organization: Philip Morris Products S.A.

ClinicalTrials.PMI@pmi.com

+41 58 242 11 11

Study Officials

• Christelle Haziza, PhD

  Philip Morris Products SA

  STUDY CHAIR

• Vasilyuk V Bogdanovich, MD

  LLC Scientific Research Center Eco-Safety

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the site staff nor the subject will be informed about the product variant the subjects have been randomized to.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double-blinded, 2-arm parallel groups, single center study

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 16, 2019
• Study Start: April 23, 2019
• Primary Completion: August 14, 2019
• Study Completion: October 25, 2019
• Last Updated: December 14, 2020
• Results First Posted: December 14, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)